BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS ENDOVASCULAR-I GUIDEWIRE

    MDR report key: 595937 · Received April 21, 2005

    Report

    Report Number
    3003778388-2005-00003
    Event Type
    Malfunction
    Date Received
    April 21, 2005
    Date of Event
    March 25, 2005
    Report Date
    April 20, 2005
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THE GUIDEWIRE THROUGH A 6F MEDTRONIC LEAD IN THE CORONARY VEIN, THE WIRE TIP SEPARATED. THE BODY OF THE WIRE WAS REMOVED. THE DISTAL TIP WAS VISIBLE IN THE POSTERIOR VEIN UNDER FLUROSCOPY. WHILE TESTING THE LEAD IN THE FIRST POSTION DR. DECIDED TO CHANGE THE 4F LEAD FOR A 6F BI-POLAR. THE NEW LEAD WAS LOADED WITH THE CRONUS I WIRE AND WE AGAIN WERE ABLE TO ADVANCE THE LEAD INTO THE POSTERIOR VEIN. DR. DECIDED TO WITHDRAW THE WIRE AND NOTICED UNDER FLUORO THAT THE WIRE TIP WAS NOT MOVING EVENT WHILE PULLING BACK ON THE LEAD. DR. THEN REMOVED THE LEAD UNDER FLURO AND NOTICED THAT THE DISTAL RADIOPAQUE SECTION OF THE WIRE WAS LODGED IN THE VEIN. THEY THEN DECIDED TO CONTINUE WITH THE PROCEDURE AND ADVANCED THE MEDTRONIC 6F LEAD OVER A WHISPER GUIDEWIRE INTO THE SAME VEIN. AS THEY MANIPULATED THE WHISPER WIRE THE REMAINED OF THE CRONUS I WIRE BECAME DISLODGED AND FOLLOWED THE COURSE OF FLOW INTO THE PT'S ANATOMY. AT THE TIME OF DISCHARGED FROM THE LAB THE PT DID NOT EXHIBIT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS ENDOVASCULAR-I GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001263-3 0412-4118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention MEDTRONIC 4F & 6F BIV LEADS, GUIDANT WHISPER WIRE